jRCTs031220008进行中（未招募）不适用
Exploratory study investigating the efficacy, safety of prophylactic olanzapine for opioid-induced nausea and vomiting in patients with cancer (JORTC-PAL20)
未提供0 个研究点目标入组 35 人开始时间: 2022年6月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histologically or clinically malignant disease
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
- •Patients with moderate to severe cancer pain needed to treat with opioid analgesics as morphine, oxycodone,hydromorphone, etc
- •Ability to provide informed written consent
- •An age of > =18 years
- •Capable to take medicine orally
- •A life expectancy of 4 weeks or longer
- •Able to complete study assessments and complying with the study procedures
排除标准
- •Diabetes mellitus
- •Had vomiting or nausea (> =CTCAE grade2)
- •Symptomatic intracranial disease as brain metastasis,nerve dissemination
- •Had received radiotherapy to the head, abdomen, or pelvis within 6 days before and during the study period
- •Had received new drugs with emetic or antiemetic action within 48 hours before study initiation
- •Had received regular strong opioid analgesics within 1 month before study initiation
- •Had a history of hypersensitivity or any contraindication to olanzapine
- •Had received new chemotherapeutic agents within 1 week before treatment with the study drug and during the study period.
结局指标
主要结局
-
Complete control rate during the 5 days of treatment with initiation of olanzapine.
次要结局
- Complete Response Rate(5 days of treatment)
- Total Control Rate(5 days of treatment)
- Time to the first emetic episode
- Time to the first rescue antiemetics administration
- Nausea numerical rating scale
- FACT-G
- Pain numerical rating scale
- Time to Treatment Failure
- Proportion of patients with no emetic episode(study period)
- Cumulative number of emetic episodes(study period)
- Proportion of patients with no nausea, no moderate nausea
- Proportion of patients with no rescue antiemetics(study period)
- Cumulative number of rescues antiemetics(study period)
- Oral intake
- Adverse events
- Opioid daily dose
- ESAS-j
- Patient satisfaction
- Feasibility